Clinical Research: Phase 1 - Phase 4

Premier Insight 277: Optimizing Enrollment for a Phase 3 Clinical Trial During a Global Pandemic

Background A biopharmaceutical company focused on delivering innovative products for women’s health chose us to manage their Phase 3 clinical trial evaluating an investigational, thermosetting, bioadhesive hydrogel for bacterial vaginosis (BV). We leveraged our expertise in study design and execution along with our extensive network of OB/GYNs to deliver a successful clinical study ahead of...

Study Start-Up

Premier Insight 275: Streamlining Regulatory Submissions for a Novel Advanced Therapy Medicinal Product Trial

Background The European regulatory landscape for advanced therapy medicinal products (ATMPs) is complex and the approval pathway depends on product classification. The EMA’s Committee for Advanced Therapies (CAT) is responsible for providing scientific recommendations on the classification of ATMPs as either gene therapy medicinal products (GTMPs), somatic cell therapy medicinal products (sCTMPs), tissue-engineered products (TEPs),...

Premier Insight 274: Site Selection, Manufacturing, and Long-Term Follow-Up in a Transition Phase 1/2 Gene Therapy Trial

Background Designing and conducting a gene therapy trial is a complex undertaking. Understanding, planning for, and overcoming the myriad of challenges of operationalizing these studies will help you bring safe, breakthrough treatments to patients with unmet medical needs. Premier Research recently faced these challenges firsthand while operationalizing a transition Phase 1/2 trial involving localized administration...

Patient and Stakeholder Engagement

Premier Insight 273: Conclusive & Positive Results Delivered Ahead of Time – By Eight Months

Background Patients rushed to enroll almost as soon as word of the study got out. We were dealing with a significant unmet need: Most patients with Binge Eating Disorder (BED) seek help from psychiatrists, nutritionists, or obesity specialists. But there was no approved, effective pharmacologic treatment. And patients desperately wanted one. Objective With unanticipated interest...

Clinical Research: Phase 1 - Phase 4

Premier Insight 272: Delivering the Global Expertise Required to Coordinate a Pediatric Gene Therapy Trial

With their potential for long-term or even curative efficacy, gene therapies are of great interest to researchers, clinicians, patients and caregivers alike. But coordinating and conducting a global, multi-center gene therapy trial is a complex, high-risk undertaking. Beyond the usual protocols and procedures required to ensure patient safety and data quality, gene therapy studies must...

Patient and Stakeholder Engagement

Premier Insight 270: A Rosacea Trial Failed Many Enrollment Hurdles.

Two large, parallel trials with 107 sites spread across the United States. Heavy competition for patients because of multiple competing treatments already on the market. And an advertising strategy that needed to attract more than 1,400 subjects fast enough to meet the sponsor’s aggressive schedule. Those were just some of the challenges we faced when...

Clinical Research: Phase 1 - Phase 4

Premier Insight 267: From KOLs to Patient Advocates, Using Every Tool to Fight a Rare Disease

Finding patients for trials in very rare conditions is difficult under any circumstances, and in this case the odds were really stacked high against success. The indication: a basal cell carcinoma known as Gorlin syndrome, a disease that manifests itself in large numbers of benign tumors that grow on various parts of the body. The...

Clinical Research: Phase 1 - Phase 4

Premier Insight 237: That Was Easy

Regulatory Submission Filed a Full Year Ahead of Schedule This case is a story with no drama. No sudden crisis.  No last-minute rescues. It’s about a clinical trial that ran perfectly from start to finish. And that in itself is a story worth telling. The sponsor needed to test a new nonsteroidal anti-inflammatory drug (NSAID)....

Data Management & Biostatistics

Premier Insight 247: Forty Percent Savings in Four Weeks: Yeah, We’re That Good

A U.S. pharmaceutical company needed an immediate outsourcing solution to replace an underperforming vendor. Not only was time critical, cost was, too. These new data specialists would be located offshore to reduce the sponsor’s overhead. Oh, and did we mention it had to be done fast? Higher performance, lower cost Premier Research stepped in and...

Functional Service Provider (FSP)

Premier Insight 246: Transfer and Re-Engage: A Powerful Path to Flexibility and Cost Savings

Functional outsourcing can produce significant savings and greatly increase flexibility in assigning resources. But any big change in staffing requires care to avoid personnel disruptions, keep projects on track, and comply with laws governing use of contract employees. Continuity matters Through its transfer and re-engagement strategy, Premier Research helps customers realize the productivity and cost...